NCT01627106撤回4 期
A Multicentered, Randomized, Open-Label, Pragmatic Use Study Comparing Vernakalant Therapy to Amiodarone Therapy in Acute Management of Recent Onset Atrial Fibrillation
Advanz Pharma0 个研究点开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Number of participants discharged from the emergency room (ER) to home, home-equivalent, or long-term care facility (LTCF) within 12 hours from randomization
研究概览
简要总结
This study will compare vernakalant therapy to amiodarone therapy in the acute management of recent onset atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic AF (duration of current episode is ≤7 days), which is hemodynamically stable, and participant has no other condition at the time of screening that may result in acute hospitalization
- •If female and of reproductive potential, the patient agrees to remain abstinent or use 2 acceptable methods of birth control from time of screening until 30-day follow-up.
- •Weigh at least 45 kg
- •Receiving adequate anticoagulant therapy
排除标准
- •Hypersensitivity to the vernakalant or amiodarone or to citric acid, sodium chloride, sodium hydroxide, or iodine
- •Severe aortic stenosis
- •Systolic blood pressure <100 mmHg
- •New York Heart Association (NYHA) Class III or IV heart failure
- •Severe bradycardia, sinus node dysfunction, or second and third degree heart block in the absence of a pacemaker
- •Use of IV rhythm control anti-arrhythmics (Class I and III) within 4 hours of study drug administration
- •Acute coronary syndrome (including myocardial infarction) within previous 30 days
- •History of thyroid dysfunction
- •Severe acute respiratory failure or cardiovascular collapse
- •Participating in another drug study or has received an investigational drug within 30 days prior to enrollment
- •Pregnant or breast-feeding, or expecting to conceive from time of screening until 30-day follow-up
研究组 & 干预措施
Vernakalant
Experimental
干预措施: Vernakalant (Drug)
Amiodarone
Active Comparator
干预措施: Amiodarone (Drug)
结局指标
主要结局
Number of participants discharged from the emergency room (ER) to home, home-equivalent, or long-term care facility (LTCF) within 12 hours from randomization
时间窗: Up to 12 hours from randomization
次要结局
- Number of participants admitted to hospital directly from the ER after randomization(Day 1 (time of ramdomization))
研究者
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